Bi-directional stent delivery system

Abstract

A bi-directional stent delivery system includes an inner elongate shaft, a radially expandable prosthesis disposed over the inner elongate shaft, an outer elongate shaft, and a shuttle sheath disposed over the radially expandable prosthesis. The distal portion of the inner shaft is releasably coupled to the distal portion of the shuttle sheath, and the distal portion of the outer shaft is releasably coupled the proximal portion of the shuttle sheath. Distal advancement of the inner shaft advances the shuttle sheath distally when the outer shaft is uncoupled from the shuttle sheath, thereby allowing the prosthesis to radially expand from a proximal end to a distal end. Proximal retraction of the outer shaft retracts the shuttle sheath proximally when the inner shaft is uncoupled from the shuttle sheath, thereby allowing the prosthesis to radially expand from a distal end to a proximal end thereof.

What is claimed is: 
     
       1. A bi-directional stent delivery system, said system comprising:
 an elongated inner shaft having a proximal portion and a distal portion; 
 a radially expandable prosthesis disposed over the inner shaft, the prosthesis having a radially collapsed configuration and a radially expanded configuration, wherein in the collapsed configuration the prosthesis is adapted to be delivered through a vasculature, and in the expanded configuration the prosthesis engages a vessel wall; 
 an elongated outer shaft having a proximal portion and a distal portion; and 
 a shuttle sheath having a proximal portion and a distal portion, the shuttle sheath disposed over the radially expandable prosthesis, the distal portion of the shuttle sheath releasably lockable to the distal portion of the inner shaft via a distal coupling mechanism, and the proximal portion of the shuttle sheath releasably lockable to the distal portion of the outer shaft via a proximal coupling mechanism, 
 wherein the stent delivery system is configured to be selectively actuated between a proximal deployment configuration and a distal deployment configuration, when the stent delivery system is in the proximal deployment configuration, the shuttle sheath is locked with the inner shaft and unlocked from the outer shaft such that distal advancement of the inner shaft advances the shuttle sheath distally relative to the outer shaft, thereby allowing the prosthesis to radially expand from a proximal end thereof to a distal end thereof, and 
 when the stent delivery system is in the distal deployment configuration, the shuttle sheath is unlocked from the inner shaft and locked with the outer shaft such that proximal retraction of the outer shaft retracts the shuttle sheath proximally relative to the inner shaft, thereby allowing the prosthesis to radially expand from the distal end thereof to the proximal end thereof. 
 
     
     
       2. The system of  claim 1 , wherein the shuttle sheath constrains the prosthesis such that a portion of the prosthesis disposed under a portion of the shuttle sheath is constrained in the radially collapsed configuration at least until the portion of the shuttle sheath is removed from over the portion of the prosthesis to allow to the prosthesis to radially expand to the radially expanded configuration. 
     
     
       3. The system of  claim 1 , wherein the distal coupling mechanism comprises a bayonet coupling. 
     
     
       4. The system of  claim 3 , the bayonet coupling further comprising a male connector with at least one pin and a female connector having a slot configured to receive the at least one pin. 
     
     
       5. The system of  claim 4  wherein the slot comprises a linear section and a transverse section that extends from the linear section in an orientation transverse to an orientation of the linear section. 
     
     
       6. The system of  claim 5  wherein the transverse section is oriented at a 90 degree angle from the orientation of the linear section. 
     
     
       7. The system of  claim 5 , wherein the slot further comprises a receiver section that extends from the transverse section, the receive section including a flared end having a diameter that is greater than a diameter of each of the linear section and the transverse section. 
     
     
       8. The system of  claim 5 , wherein the transverse section is oriented at about a 45 degree angle from the orientation of the linear section. 
     
     
       9. The system of  claim 5 , wherein the transverse section is oriented at an angle between 60 and 150 degrees relative to the orientation of the linear section. 
     
     
       10. The system of  claim 4  wherein the width of the slot is narrowed at one portion so as to form a friction fit with the at least one pin. 
     
     
       11. The system of  claim 4  wherein the female connector has two or more slots of similar configuration with the two or more slots arranged equidistant from one another around the circumference of the female connector. 
     
     
       12. The system of  claim 4 , wherein the slot extends through a sidewall of the female connector. 
     
     
       13. The system of  claim 4 , wherein the slot comprises a transverse section that curves along an arc of about 90 degrees. 
     
     
       14. The system of  claim 4 , wherein the male connector is disposed on one of the shuttle sheath or the inner shaft, and the female connector is disposed on the other of the shuttle sheath or the inner shaft. 
     
     
       15. The system of  claim 4 , wherein the at least one pin is disposed directly on at least one of the inner shaft or a middle shaft that is slidably disposed over the inner shaft and within the outer shaft. 
     
     
       16. The system of  claim 1 , wherein the distal coupling mechanism comprises a threaded region on the distal portion of the inner shaft and a corresponding threaded region on the distal portion of the shuttle sheath. 
     
     
       17. The system of  claim 1 , wherein the distal coupling mechanism comprises a helical region on the distal portion of the inner shaft and a corresponding helical region on the distal portion of the shuttle sheath. 
     
     
       18. The system of  claim 1 , wherein the distal coupling mechanism comprises one or more of a snap fit, an interference fit, a barbed connector, a locking mechanism, a rotatable key lock, a linear key lock, a threaded bushing, a twist lock, a magnetic coupling, or a frangible connector. 
     
     
       19. The system of  claim 1 , wherein the proximal coupling mechanism comprises a bayonet coupling. 
     
     
       20. The system of  claim 1 , wherein the proximal coupling mechanism comprises a threaded region on the distal portion of the outer shaft and a corresponding threaded region on the proximal portion of the shuttle sheath. 
     
     
       21. The system of  claim 1 , wherein the proximal coupling mechanism comprises a helical region on the distal portion of the outer shaft and a corresponding helical region on the proximal portion of the shuttle sheath. 
     
     
       22. The system of  claim 1 , wherein the proximal coupling mechanism comprises one or more of a snap fit, an interference fit, a barbed connector, a locking mechanism, a rotatable key lock, a linear key lock, a threaded bushing, a twist lock, a magnetic coupling, or a frangible connector. 
     
     
       23. The system of  claim 1 , wherein the distal coupling mechanism is a first bayonet coupling mechanism having a first slot in a first orientation, and the proximal coupling mechanism is a second bayonet coupling mechanism having a second slot in a second orientation opposite the first orientation of the first slot, and wherein rotation of the inner shaft in a first direction locks the first bayonet coupling mechanism and rotation of the inner shaft in a second direction opposite the first direction unlocks the first bayonet coupling mechanism, and wherein rotation of the outer shaft in the first direction unlocks the second bayonet coupling mechanism and rotation of the outer shaft in the second direction locks the second bayonet coupling mechanism. 
     
     
       24. The system of  claim 23  wherein each of the first and second slots comprises a linear section, a transverse section and a receiver section. 
     
     
       25. The system of  claim 24  wherein the transverse section is oriented at a 90 degree angle from an orientation of the linear section. 
     
     
       26. The system of  claim 23  wherein the width of each of the first and second slots is narrowed at one portion so as to form a friction fit with a portion of the respective coupling mechanism. 
     
     
       27. The system of  claim 26  wherein the portion of the respective coupling mechanism is a pin. 
     
     
       28. The system of  claim 1 , wherein the distal portion of the inner shaft is coupled to a nosecone, the distal coupling mechanism releasably locks the distal end of the shuttle sheath with the distal end of the inner shaft via the nosecone. 
     
     
       29. The system of  claim 1 , wherein the distal coupling mechanism is a left-handed bayonet coupling, and the proximal coupling mechanism is a right-handed bayonet coupling. 
     
     
       30. The system of  claim 1 , further comprising a handle coupled to the inner shaft and the outer shaft, the handle including a longitudinal body and a torquer that is rotatable relative to the body, wherein rotation of the torquer in one direction causes rotation of at least one of the outer shaft or the inner shaft in the same direction. 
     
     
       31. The system of  claim 30 , wherein the torquer is configured to selectively lock and unlock the distal portion of the outer shaft to the proximal portion of the shuttle sheath via the proximal coupling mechanism. 
     
     
       32. The system of  claim 30 , wherein the torquer is configured to selectively lock and unlock the distal portion of the shuttle sheath to the distal portion of the inner shaft via the distal coupling mechanism. 
     
     
       33. The system of  claim 30 , further comprising a selector switch on the handle that determines a direction that the torquer is allowed to rotate relative to the body of the handle, the selector switch being movable between a first position and a second position. 
     
     
       34. The system of  claim 33 , wherein the stent delivery system is selectively actuated between the proximal deployment configuration and the distal deployment configuration by moving the selector switch between the first and second positions. 
     
     
       35. The system of  claim 33 , wherein when the selector switch is in the first position the torquer is allowed to rotate in a clockwise direction only, and when the selector switch is in the second position the torquer is allowed to rotate in a counterclockwise direction only. 
     
     
       36. The system of  claim 35 , wherein rotation of the torquer in the clockwise direction when the selector switch is in the first position unlocks the distal coupling mechanism between the inner shaft and the shuttle sheath while retaining the proximal coupling mechanism in a locked state such that proximal retraction of the outer shaft retracts the shuttle sheath proximally relative to the inner shaft, allowing the prosthesis to radially expand from the distal end to the proximal end thereof. 
     
     
       37. The system of  claim 35 , wherein rotation of the torquer in the counterclockwise direction when the selector switch is in the second position unlocks the proximal coupling mechanism between the outer shaft and the shuttle sheath while retaining the distal coupling mechanism in a locked state such that distal advancement of the inner shaft advances the shuttle sheath distally relative to the outer shaft, allowing the prosthesis to radially expand from the proximal end to the distal end thereof. 
     
     
       38. The system of  claim 30 , further comprising a distal slider disposed on the body of the handle, the distal slider coupled to the outer shaft such that proximal movement of the distal slider relative to the body produces proximal movement of the outer shaft relative to the inner shaft. 
     
     
       39. The system of  claim 38 , wherein the body of the handle includes threads, the distal slider configured to rotate on the threads of the body in a first mode of operation to provide fine translation of the outer shaft in at least one of a proximal direction or a distal direction relative to the inner shaft. 
     
     
       40. The system of  claim 39 , wherein the distal slider includes a release button, the distal slider configured to decouple from the threads of the body when the release button is actuated to allow the distal slider to translate along the body in a second mode of operation to provide rapid translation of the outer shaft in at least one of the proximal or distal directions. 
     
     
       41. The system of  claim 30 , further comprising a proximal slider disposed on the body of the handle, the proximal slider coupled to the inner shaft such that distal movement of the proximal slider relative to the body produces distal movement of the inner shaft relative to the outer shaft. 
     
     
       42. The system of  claim 41 , wherein the body of the handle includes threads, the proximal slider configured to rotate on the threads of the body in a first mode of operation to provide fine translation of the inner shaft in at least one of a proximal direction or a distal direction relative to the outer shaft. 
     
     
       43. The system of  claim 42 , wherein the proximal slider includes a release button, the proximal slider configured to decouple from the threads of the body when the release button is actuated to allow the proximal slider to translate along the body in a second mode of operation to provide rapid translation of the inner shaft in at least one of the proximal or distal directions. 
     
     
       44. A bi-directional stent delivery system comprising:
 an elongated inner shaft having a proximal portion and a distal portion; 
 a radially expandable prosthesis disposed over the inner shaft, the prosthesis having a radially collapsed configuration and a radially expanded configuration, wherein in the collapsed configuration the prosthesis is adapted to be delivered through a vasculature, and in the expanded configuration the prosthesis engages a vessel wall; 
 an elongated outer shaft having a proximal portion and a distal portion; 
 a shuttle sheath having a proximal portion and a distal portion, the shuttle sheath disposed over the radially expandable prosthesis, the distal portion of the shuttle sheath releasably lockable to the distal portion of the inner shaft via a distal coupling mechanism, and the proximal portion of the shuttle sheath releasably lockable to the distal portion of the outer shaft via a proximal coupling mechanism; and 
 a handle including a longitudinal body and a torquer that is rotatable relative to the body, wherein rotation of the torquer in one direction causes rotation of at least one of the outer shaft or the inner shaft in the same direction, wherein rotation of the torquer is used to selectively lock and unlock at least one of the distal coupling mechanism or the proximal coupling mechanism, 
 wherein the stent delivery system is configured to be selectively actuated between a proximal deployment configuration and a distal deployment configuration by moving a selector switch on the handle between first and second positions, the first and second positions of the selector switch each allow the torquer to rotate relative to the body in only one direction, and the direction of rotation of the torquer determines the locking and unlocking of the respective distal and proximal coupling mechanisms. 
 
     
     
       45. The system of  claim 44 , wherein the stent delivery system is configured to, when the stent delivery system is in the proximal deployment configuration, lock the shuttle sheath with the inner shaft and unlock the shuttle sheath from the outer shaft such that distal advancement of the inner shaft advances the shuttle sheath distally relative to the outer shaft, thereby allowing the prosthesis to radially expand from a proximal end thereof to a distal end thereof, and when the stent delivery system is in the distal deployment configuration, and configured to unlock the shuttle sheath from the inner shaft and lock the shuttle sheath with the outer shaft such that proximal retraction of the outer shaft retracts the shuttle sheath proximally relative to the inner shaft, thereby allowing the prosthesis to radially expand from the distal end thereof to the proximal end thereof. 
     
     
       46. The system of  claim 44 , wherein when the selector switch is in the first position the torquer is allowed to rotate in a clockwise direction only, and when the selector switch is in the second position the torquer is allowed to rotate in a counterclockwise direction only. 
     
     
       47. The system of  claim 46 , wherein rotation of the torquer in the clockwise direction when the selector switch is in the first position unlocks the distal coupling mechanism between the inner shaft and the shuttle sheath while retaining the proximal coupling mechanism in a locked state such that proximal retraction of the outer shaft retracts the shuttle sheath proximally relative to the inner shaft, allowing the prosthesis to radially expand from the distal end to the proximal end thereof. 
     
     
       48. The system of  claim 46 , wherein rotation of the torquer in the counterclockwise direction when the selector switch is in the second position unlocks the proximal coupling mechanism between the outer shaft and the shuttle sheath while retaining the distal coupling mechanism in a locked state such that distal advancement of the inner shaft advances the shuttle sheath distally relative to the outer shaft, allowing the prosthesis to radially expand from the proximal end to the distal end thereof. 
     
     
       49. The system of  claim 44 , further comprising a distal slider disposed on the body of the handle, the distal slider coupled to the outer shaft such that proximal movement of the distal slider relative to the body produces proximal movement of the outer shaft relative to the inner shaft. 
     
     
       50. The system of  claim 49 , wherein the body of the handle includes threads, the distal slider configured to rotate on the threads of the body in a first mode of operation to provide fine translation of the outer shaft in at least one of a proximal direction or a distal direction relative to the inner shaft. 
     
     
       51. The system of  claim 50 , wherein the distal slider includes a release button, the distal slider configured to decouple from the threads of the body when the release button is actuated to allow the distal slider to translate along the body in a second mode of operation to provide rapid translation of the outer shaft in at least one of the proximal or distal directions. 
     
     
       52. The system of  claim 44 , further comprising a proximal slider disposed on the body of the handle, the proximal slider coupled to the inner shaft such that distal movement of the proximal slider relative to the body produces distal movement of the inner shaft relative to the outer shaft. 
     
     
       53. The system of  claim 52 , wherein the body of the handle includes threads, the proximal slider configured to rotate on the threads of the body in a first mode of operation to provide fine translation of the inner shaft in at least one of a proximal direction or a distal direction relative to the outer shaft. 
     
     
       54. The system of  claim 53 , wherein the proximal slider includes a release button, the proximal slider configured to decouple from the threads of the body when the release button is actuated to allow the proximal slider to translate along the body in a second mode of operation to provide rapid translation of the inner shaft in at least one of the proximal or distal directions. 
     
     
       55. The system of  claim 44 , wherein the distal coupling mechanism is a bayonet coupling, the bayonet coupling including at least one pin on one of the distal portion of the inner shaft or the distal portion of the shuttle sheath, the bayonet coupling further including at least one slot that is configured to receive the at least one pin on the other of the distal portion of the inner shaft or the distal portion of the shuttle sheath. 
     
     
       56. The system of  claim 55 , wherein rotation of the torquer causes movement of the at least one pin relative to the at least one slot to selectively lock and unlock the distal coupling mechanism. 
     
     
       57. The system of  claim 55 , wherein the at least one slot comprises a linear section and a transverse section that extends from the linear section in an orientation transverse to an orientation of the linear section. 
     
     
       58. The system of  claim 57 , wherein the transverse section is oriented at an angled between 60 and 150 degrees relative to the orientation of the linear section. 
     
     
       59. The system of  claim 58 , wherein the transverse section is oriented at a 90 degree angle from the orientation of the linear section. 
     
     
       60. The system of  claim 57 , wherein the transverse section is oriented at about a 45 degree angle from the orientation of the linear section. 
     
     
       61. The system of  claim 57 , wherein the at least one slot further comprises a receiver section that extends from the transverse section, the receiver section including a flared end having a diameter that is greater than a diameter of each of the linear section and the transverse section, the receiver section configured to receive the at least one pin to lock the distal coupling mechanism. 
     
     
       62. The system of  claim 44 , wherein the proximal coupling mechanism is a bayonet coupling, the bayonet coupling including at least one pin on one of the distal portion of the outer shaft or the proximal portion of the shuttle sheath, the bayonet coupling further including at least one slot that is configured to receive the at least one pin on the other of the distal portion of the outer shaft or the proximal portion of the shuttle sheath. 
     
     
       63. The system of  claim 62 , wherein rotation of the torquer causes movement of the at least one pin relative to the at least one slot to selectively lock and unlock the proximal coupling mechanism. 
     
     
       64. The system of  claim 62 , wherein the at least one slot comprises a linear section and a transverse section that extends from the linear section in an orientation transverse to an orientation of the linear section. 
     
     
       65. The system of  claim 64 , wherein the transverse section is oriented at an angled between 60 and 150 degrees relative to the orientation of the linear section. 
     
     
       66. The system of  claim 65 , wherein the transverse section is oriented at a 90 degree angle from the orientation of the linear section. 
     
     
       67. The system of  claim 64 , wherein the transverse section is oriented at about a 45 degree angle from the orientation of the linear section. 
     
     
       68. The system of  claim 64 , wherein the at least one slot further comprises a receiver section that extends from the transverse section, the receiver section including a flared end having a diameter that is greater than a diameter of each of the linear section and the transverse section, the receiver section configured to receive the at least one pin to lock the proximal coupling mechanism. 
     
     
       69. The system of  claim 44 , wherein the shuttle sheath constrains the prosthesis such that a portion of the prosthesis disposed under a portion of the shuttle sheath is constrained in the radially collapsed configuration at least until the portion of the shuttle sheath is removed from over the portion of the prosthesis to allow to the prosthesis to radially expand to the radially expanded configuration. 
     
     
       70. The system of  claim 44 , wherein the distal coupling mechanism is a left-handed bayonet coupling, and the proximal coupling mechanism is a right-handed bayonet coupling such that rotating the torquer in one direction unlocks only one of the distal coupling mechanism or proximal coupling mechanism.